Fatigue in MS: From Invisible to Measurable (FIMS)

University Medical Center Groningen (UMCG)

Status: Enrolling

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Other

Identifiers

NCT07182903

19721

Details and patient eligibility

About

Fatigue is one of the most common and burdensome symptoms of MS, but its precise cause remains unknown, and an effective treatment is lacking. Previous research has shown that the progression of MS is associated with a higher presence of a specific type of T-cell, the cytotoxic CD4+ T-cells, which play a role in the immune system.

The aim of this study is to investigate whether these cells can also be linked to fatigue in people with MS.

Full description

Forty individuals with MS will be asked to complete questionnaires about fatigue and perform motor tasks. Additionally, blood samples will be taken to measure the levels of cytotoxic CD4+ T-cells. These values will then be correlated with fatigue scores and performance on the motor tasks.

Scores from the fatigue questionnaires and decline in amplitude and frequency from the performance fatiguability test will be correlated to the level of CD4 CTLs from the blood samples. Secondary study parameters include muscle activation patterns measured by EMG, distance walked on 6MWT and voluntary muscle activation.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of relapsing remittion, primary progressive or secondary progressive MS
• Age: 18-60 years
• Ability to perform the foot-tapping task
• Ability to walk at least 20 meters (with or without walking aid)

Exclusion criteria

• Dimethyl fumarate, fingolimod or alemtuzumab treatment, since these medications have a strong influence on the immune system As a result of these treatments, there are few to no immune cells circulating in the blood, meaning we cannot find our population of interest in the blood.
• Change in medication 6 weeks before the start of the study (including medication not related to MS) - MS relapse within 6 weeks of the start of the study
• Had an infection in the last month - Received a vaccination in the last 14 days - Pregnant or pregnancy in the last 6 months
• Having a psychiatric disorder
• Having a neurological disorder other than MS
• Having cognitive or communicative problems that makes it hard to follow instructions

Trial design

40 participants in 1 patient group

MS

Description:

Participants with multiple sclerosis